BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3903892 · Received June 30, 2014

    Report

    Report Number
    2531779-2014-18676
    Event Type
    Malfunction
    Date Received
    June 30, 2014
    Report Date
    June 23, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 11/26/2014 WITH THE FOLLOWING FINDINGS: ANIMAS HAS CONDUCTED A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS PUMP AND CONFIRMED THAT IT WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AT THE TIME OF RELEASE. DURING A VISUAL INSPECTION OF THE PUMP, NO DAMAGE WAS FOUND TO THE DISPLAY LENS OR SCREEN.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A DISPLAY (DAMAGED) ISSUE. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT WITH THIS COMPLAINT. THERE WAS NO FURTHER INFORMATION AVAILABLE REGARDING THE COMPLAINT AT THIS TIME; IF FURTHER INFORMATION IS PROVIDED A FOLLOW UP REPORT SHALL BE MADE. THIS COMPLAINT IS BEING REPORTED BECAUSE OF THE ALLEGATION OF A DISPLAY ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    381103 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR